A peptic ulcer is a focal mucosal defect with inflammatory cell infiltration and coagulation necrosis extending through the muscularis mucosae. The overall concept of the pathophysiology of peptic ulcer disease (PUD) is that there is a disturbed equilibrium between the aggressive and protective factors, with a very complex interplay between the factors. Peptic ulcers, characterized by a damaged gastric mucosal barrier, tend to occur within the section of the gastrointestinal (GI) tract that is in contact with gastric juice containing acid and pepsin. The gastric mucosal barrier is the feature of the stomach that allows it to safely contain the gastric acid required for digestion. The predilection sites for ulcers are the vicinity of mucosal junctions such as the transitional zone between the esophageal and gastric mucosa and the gastro-duodenal junction. PUD is commonly associated with gastritis and it is generally accepted that colonization by the bacterium H. pylori is causatively related to gastritis associated with PUD.
Carafate® suspension (Sucralfate suspension) is available in the United States as an oral suspension. It was approved in 1993 for the treatment of active duodenal ulcers. It is also widely used for the treatment of PUD, gastritis due to gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), non-erosive reflux disorder (NERD) and functional dyspepsia. Sucralfate may also be used to prevent recurrent ulcers after healing of the ulcer has been achieved. It is also used to relieve or prevent ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs).
The mechanism of action of sucralfate is not fully understood and several possible mechanisms have been suggested. In general, it is widely believed that sucralfate exerts its anti-ulcer activity by forming an ulcer-adherent complex with the proteinaceous exudate at the ulcer site, thus covering the ulcer site and protecting it against further attack by aggressive factors such as acid, pepsin and bile salts.
A need remains for an oral Sucralfate suspension that is safe, efficacious and cost-efficient generic drug product of Sucralfate suspension that can be developed and made available to the patient population. This discovery addresses that need by identifying sucralfate suspensions that are bioequivalents of sucralfate suspension RLD.